BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE L

    MDR report key: 19018524 · Received April 2, 2024

    Report

    Report Number
    3005180920-2024-00157
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    March 4, 2024
    Report Date
    April 2, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809255
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07 MARCH 2024. LOT 2103162: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUNE-2021. EXPIRATION DATE: 2026-06-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT INVOLVED: BATCH REVIEW PERFORMED ON 07 MARCH 2024 ON LINER: MPACT 01.32.3644HC10A FACE-CHANGING 10° PE HC LINER Ø36/E (K183582) LOT. 2009675 LOT 2103162: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUNE-2021. EXPIRATION DATE: 2026-06-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR CUP AND LINER AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051529 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE L HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 2103162 07630030809255

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention